If you have been advised that your research will need to be managed as a Clinical Trial of an Investigational Medicinal Product or as a Clinical Investigation of a Medical Device, you will be required to provide proof that the University holds appropriate insurance. This type of research is covered by the University's Clinical Trials Insurance.
If you have not done so already, the best way to provide information regarding your intended research, for you insurance needs to be assessed, is to complete a Research Registration Checklist and submit it to Research Governance.
As part of your application through the Integrated Research Application System (IRAS), you will be required to provide information about insurance. Unless you have been advised otherwise, by Research Governance, you should answer the IRAS questions as per this guidance. You will also to required to reference this cover in your Participant Information. You can find recommended wording here.
If your study will involve any of the following:
then additional cover may need to be arranged. If that is the case, please contact research-governance@bristol.ac.uk to discuss.
The Clinical Trials policy covers liability arising from the design or oversight of the study and the actions of anyone acting under the direction of the research team. However, it does not cover any harm arising from individual negligence. Essentially, if someone working for a third-party conducts a trial procedure in accordance with the relevant protocol or work-instruction, and someone comes to harm, the University's insurance will apply. However, if they did not conduct the procedure in accordance with the relevant protocol or work-instruction then the University's policy will not apply - they will be reliant upon their employer's policy or their own professional/clinical negligence cover.
